MMIT Reality Check on Cervical Cancer (2Q2023)

Payer Coverage:

A review of market access for cervical cancer treatments shows that under the pharmacy benefit, about 33% of the lives under commercial formularies are covered with utilization management restrictions. Around 65% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 54% of the lives under commercial policies are covered with utilization management restrictions. Almost 67% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 95% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 17% require multiple steps. Around 66% of payer-controlled pharmacy benefit covered lives require prior authorization, with 6% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

PARP Inhibitors’ Data on Later Line Use in Ovarian Cancer Prompts Indication Withdrawals

Since June, manufacturers of the three FDA-approved poly (ADP-ribose) polymerase (PARP) inhibitors have withdrawn their indications in the later line treatment setting for ovarian cancer. Payers should be reviewing their utilization management criteria to make sure they are covering the drugs in the appropriate setting, advises one industry expert.

FDA Approves Vegzelma

In September 2022, the FDA approved Celltrion USA’s Vegzelma (bevacizumab-adcd) for the treatment of multiple indications: (1) metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment; (2) metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen; (3) unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC, in combination with carboplatin and paclitaxel for first-line treatment; (4) recurrent glioblastoma in adults; (5) metastatic renal cell carcinoma in combination with interferon alfa; (6) persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan; (7) epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with carboplatin and paclitaxel, followed by Vegzelma as a single agent, for stage III or IV disease following initial surgical resection or in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens or in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Vegzelma as a single agent, for platinum-sensitive recurrent disease. The agent is the fourth FDA-approved biosimilar of Avastin (bevacizumab) from Genentech USA, Inc., a member of the Roche Group. Dosing for the vascular endothelial growth factor inhibitor varies according to the indication. Drugs.com lists the price of one 100 mg/4 mL (25 mg/mL) of Avastin as more than $848.

FDA Approves Alymsys

In April 2022, the FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions: (1) first- or second-line treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy; (2) second-line treatment of metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy in people who have progressed on a first-line bevacizumab product; (3) first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) recurrent glioblastoma in adults; (5) metastatic renal cell carcinoma in combination with interferon alfa; (6) persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan; and (7) epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease in people receiving no more than two prior chemotherapy regimens. The vascular endothelial growth factor inhibitor is the third biosimilar of Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab) that the agency has approved. Dosing of the intravenous infusion is based on indication.

Key Findings:

Market Events Drive Changes

In September 2022, the FDA approved Celltrion USA’s Vegzelma (bevacizumab-adcd) for the treatment of multiple indications, including for persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. In April 2022, the agency approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions, including for persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan. In October 2021, the agency gave another indication to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for the treatment of people with persistent, recurrent or metastatic cervical cancer whose tumors express programmed death-ligand 1 (PD-L1) (Combined Positive Score (CPS) > 1) as determined by an FDA-approved test. The agency also converted the June 2018 accelerated approval for the programmed death receptor-1 (PD-1) inhibitor for the treatment of people with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS > 1), as determined by an FDA-approved test, to regular approval.

Competitive Market Landscape

This is a competitive category with agents in other therapeutic market baskets and biosimilar competition.

Pharmacy, Medical Benefit Implications

Drugs in the market basket have good coverage across payers and lines of business. The majority of payers have policies in place to ensure standard of care is met and appropriate biomarker testing for targeted therapy is conducted.

Key Players in Market:

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